Royal Brompton and Harefield NHS Foundation Trust
London, United Kingdom
NCT Number: NCT01796912
The goal of this study is to determine the impact of apheresis on clinical parameters and symptoms of patients with refractory angina and raised Lp(a). The investigators will conduct a prospective, randomised controlled crossover study of 20 patients with refractory angina and raised Lp(a), randomised to undergoing lipoprotein apheresis weekly for three months or sham apheresis weekly for three months with assessment of myocardial perfusion, carotid atherosclerosis, endothelial vascular function, thrombogenesis, exercise capacity, angina symptoms and quality of life at the beginning and end of treatment. Patients will then crossover to the opposite study arm with the protocol repeated. The hypothesis is that the above parameters will be improved by lipoprotein apheresis in patients with raised Lp(a) and Refractory Angina. Investigators will also test for the genotypic presence of apolipoprotein(a) gene (LPA) locus variants (rs10455872 and rs3798220) which are thought to be associated with an increased level of Lp(a) and an increased risk of coronary disease.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
London, United Kingdom
Angina which is refractory to conventional medical therapy and revascularisation is challenging to manage. Lipoprotein(a) or Lp(a) is a genetically determined form of LDL-cholesterol, elevation of which is an independent risk factor and predictor of adverse cardiovascular events. Lp(a) is felt to increase cardiovascular risk via its prothrombotic effect and by enhancing intimal lipoprotein deposition. Lipoprotein apheresis is the most effective treatment for raised Lp(a). Lipid lowering agents such as statins have little to no effect on Lp(a) levels.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Weekly lipoprotein apheresis for 3 months
Weekly sham (placebo) apheresis for 3 months
Time frame: 3 months
Baseline compare to 3 month, changes presented Determine the impact of lipoprotein apheresis on quantitative myocardial perfusion measured by stress/rest cardiovascular magnetic resonance imaging.
Increase means better outcome
Time frame: 3 months
Changes from baseline to 3 months
Time frame: Within 7 days before and after 3 months of weekly lipoprotein apheresis
EndoPat LnRHI - natural logarithm of reactive hyperaemia index. Increase - better outcome
Time frame: 3 months
SAQ-Angina stability, increase means improvement. 0-100 scale, Higher score means improvements
Time frame: 3 months
Quality of Life score following, 0-100 score, high score improve quality of life
Time frame: 3 months
Six minute walk test, patient can walk longer distance means improvements
Time frame: 3 months
Thrombogenesis, Reduce value is better to the patients
Imperial College London
Other
Clinical Outcomes, Perfusion and Vascular Function in Patients With Refractory Angina and Raised Lipoprotein (a), Treated With Lipoprotein Apheresis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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